Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-N-2390] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter. DATES: Either electronic or written requests for a hearing must be submitted by November 10, 2022; submit data, information, and analyses in support of the hearing and any other comments by December 12, 2022. ADDRESSES: You may submit hearing requests, documents in support of the hearing, and any other comments as follows. Please note that late, untimely filed requests and documents will not be considered. The https://www.regulations.gov electronic filing system will accept hearing requests until 11:59 p.m. Eastern Time at the end of November 10, 2022, and will accept documents in support of the hearing and any other comments until 11:59 p.m. Eastern Time at the end of December 12, 2022. Documents received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before these dates. Electronic …